10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
EXMOOR BITE BUFFER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TRACHEOTEC
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948030051·TRACHEOTEC VARIO CUFF-SUCTION, SIZE 6
LEONE SPA
FDA UDI
LEONE SPA·08033707035527·WEB I MOL BANDS G8424-33+G2820-00 UL 6
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327371116·FACIAL ID-TRAUMA-6PLATES
MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system
FDA 510(k)
FDA Class 2
·Neurology
FONIX ,MODEL 8000
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 24, 2014
CHPV CYL W/LG RR NU120CM DIST
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. MEDOS S.A.·Product code JXG·October 28, 2010
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 28, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012